Implosion Day at Geron

Geron has announced that a review of an unplanned interim analysis in a 166 patient study has led it to discontinue its randomized Phase 2 study of imetelstat in metastatic HER2-negative breast cancer. If you look at the stock’s reaction you know the news is not good. The company said that median progression-free survival in the imetelstat arm was shorter than in the comparator arm.

The company did say that it is also continuing its randomized Phase 2 study of imetelstat in advanced non-small-cell lung cancer (NSCLC). However, although a separate interim analysis of the NSCLC study suggested a modest trend of efficacy in favor of the imetelstat arm, the prespecified success criteria in this trial are unlikely to be met, and, as a consequence, it is doubtful that Geron will take imetelstat forward into Phase 3 development for NSCLC.

Here is the problem. A scheduled periodic review conducted by the company’s Internal Safety Monitoring Committee reported a greater number of deaths and number of patients discontinuing paclitaxel in the imetelstat arm compared to the control arm. The progression free survival rate was only 6.2 months, versus 8.0 months for patients receiving paclitaxel alone.

Geron said that it ended the second quarter of 2012 with $122 million in cash and investments, and chances are high that it is going to need that cash more than ever now. Its stock is down 47% at $1.53 in premarket trading and the implied market cap after the drop is now only around $205 million.

JON C. OGG